| Services | - International Compliance Management |
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Regulatory Facts - Brazil
The more
informed you are, the better prepared you will be to gain share in the global
market. The below fact sheet provides general fundamentals on gaining product
approval in the targeted country.
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Total
Population: 173 Million (2000) |
GDP per capita: $6,150 (1999 est.) |
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Age Structure: |
0-14 yrs 29% |
Communication Status: Private |
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15-64 yrs 66% |
Health Care Status: National |
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65 yrs and over 5% |
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Sex Ratio: |
0.97 male(s) /female (2000 est.) |
Economic Status: Free market economy |
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Official
Language: Portuguese |
International
Organization Participation: ISO, ITU, Mercosur |
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Literacy
Rate: 83.3 % |
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The three primary areas of Telecommunications, Medical products,
and Consumer products are addressed in this Fact Sheet. For detailed information on a specific
country or product, please contact the International Compliance Management Unit
at TÜV America at icm@tuvam.com.
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Telecom |
Medical |
Consumer Products |
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Regulatory
Authority: National
Telecommunication Agency (ANATEL) |
Regulatory Authority: Ministry of Health |
Regulatory
Authority: Ministério do Desenvolvimento, Indústria e Comércio Exterior (MDIC) |
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Approval Bodies: ANATEL |
Approval Bodies: Ministry of Health |
Approval Bodies: National Institute of Metrology
Standardization & Industrial Quality (INMETRO) |
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Registration Bodies: Brazilian National Health
Vigilance Agency ANVS, National Industry Property Institute
(INPI) |
Certification Bodies: Product Certification
Bodies designated by INMETRO |
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Certification Bodies: UC, CERTUSP, DNV |
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EMC: Required
for specific products |
Safety: Accepts US product Standards & US Certification.
IEC 60601 series. |
EMC: Required for specific products |
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Safety: CB report
accepted |
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Safety: Compulsory certification is
required for certain products |
Radio:
Spectrum
assignment in place |
Radio:
Spectrum
assignment in place |
Radio:
Spectrum
assignment in place |
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Labeling:
Seal with ANATEL mark & identification number of approved product |
Labeling:
Labels should have a Portuguese translation & should use metric
units or show a metric equivalent |
Labeling:
INMETRO’s energy conservation & noise marks/ Certification Body
mark |
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Residency
Requirements: Local
presence required |
Residency
Requirements: Local presence required |
Residency
Requirements: Local presence not required |
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Current
Trends: Applicant
must have a barcode number issued by EAN for each product prior to request
for homologation. |
Currents
Trends: Only
companies based in Brazil can apply for medical product registration. |
Current
Trends: Brazilian
standards are voluntary. They become compulsory when they are published in
the official gazette. |
For more information, contact us.